Tag: FDA enforcement

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07/02/2018

False/Misleading Risk, Efficacy Claims in Online Video Cited in OPDP Enforcement Letter to Pfizer

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03/07/2018

CBER’s APLB Issues First Enforcement Letter Since 2015 for Misleading Efficacy Claims

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02/23/2018

First 2018 OPDP Enforcement Letter Targets Exhibit Booth for Opioid

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01/24/2018

OPDP Enforcement Letter Grand Total for 2017: Five

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11/30/2017

OPDP’s Third Enforcement Letter of 2017 Cites Presentation of Risks, Efficacy Claims

01/03/2017

OPDP Cites Two Companies for YouTube Videos Featuring INDs

12/21/2016

Two December Warning Letters Bring 2016 Tally Up to Three

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12/15/2016

OPDP Sends Two Letters Citing Major Statement Treatment in TV Ad Claims

11/08/2016

Report from the Coalition Executive Director